Overview: A Validated Solution for CPET Clinical Data
The customer sought assistance to create and qualify a custom CPET Analysis Workbook (CPET Workbook). Discrete steps and activities were required to create and collectively demonstrate the CPET Workbook's capability to meet the defined business and regulatory requirements and provide a high degree of confidence in the design and deployment of the CPET Workbook.
The Challenge
The customer needed a validated solution to analyze their cardiopulmonary exercise test (CPET) clinical data, but their existing process was slow, manual, and prone to error.
- The previous solution required manual manipulations, calculations, and data transcriptions.
- QC verification of data often uncovered human error.
- The customer received inconsistently formatted data from investigator sites.
- The existing workbook had various anomalies and required modifications to analyze different data set types.
Manual transcription and unverified formulas are exactly the conditions that put data integrity at risk, so any replacement had to be both efficient and provably reliable.
The USDM Approach
USDM created a customized CPET analysis workbook designed to remove manual steps and standardize how data was processed. The workbook:
- Used formulas and macros for importing raw CPET data
- Converted data to rolling averages
- Calculated endpoints according to study protocol
To make the tool trustworthy and defensible, USDM then:
- Validated the custom CPET analysis workbook
- Secured the workbook with locked formulas and macros
- Automated the workbook's calculations
A Risk-Based, Validation-First Mindset
By locking formulas and macros and automating the calculations, USDM closed off the manual entry points where human error had been introduced. This risk-based approach aligns with modern computer software assurance (CSA) thinking and the recordkeeping expectations of 21 CFR Part 11, focusing validation effort on the steps that most affect data quality.
The Results
The validated workbook delivered measurable gains in both speed and reliability:
- 75% decrease in QC verification time and effort
- 25% decrease in analysis time
- A customized, automated, and validated workbook delivered to the customer
By replacing fragile manual spreadsheets with a secured, automated, and validated tool, USDM gave the customer a faster path from raw CPET data to protocol endpoints, while reducing the human errors that QC had been catching. The result is a repeatable, audit-ready solution that protects clinical data integrity as part of an ongoing continuous compliance posture.